ARTICLE SUMMARY:
Officials from some notified bodies say proposals to update the EU Medical Device and IVD Regulations go too far in tying their hands and taking away important authorities that allow them to ensure quality medical devices and diagnostics reach the market.
In a bid to protect access to needed technologies and shore up the global competitiveness of the EU medtech sector, Europe is pressing to significantly cut down on regulatory burdens for device and diagnostic manufacturers. Policymakers claim that proposals unveiled in December to reform the Medical Device and IVD Regulations would save €3.3 billion per year, largely by reducing administrative costs to device firms and government agencies.
But officials at notified bodies, which are charged with handling the on-the-ground oversight of devices under Europe’s framework, say the plans are based on some faulty assumptions and would potentially threaten their ability to ensure patient safety. While signaling support for multiple elements of the MDR/IVDR revisions, notified body representatives say that the proposals may go too far in tying their hands and taking away important authorities that allow them to accomplish their basic mission.
“We see ourselves as a key part of the regulatory system and as a key player in making sure that the best products get to patients,” said Graeme Tunbridge, senior VP of global regulatory and quality for BSI’s notified body, in an interview. But the European Commission proposal, he laments, appears to frame many activities conducted by notified bodies as unnecessary bureaucracy. “The sense, from our perspective, is that there is an overfocus on notified bodies as the main cost driver within the system and as the main tool that the Commission is looking to use to be able to make cost savings,” Tunbridge notes.
